Colon to Rectum
Gut. 2022;71(12):2430–8
Double-blinded randomized placebo-controlled trial of enterosgel (polymethylsiloxane polyhydrate) for the treatment of IBS with diarrhea (IBS-D)
Objective: Irritable bowel syndrome with diarrhea (IBS-D) is a common and challenging condition that significantly reduces quality of life. Enterosgel (polymethylsiloxane polyhydrate) is an intestinal adsorbent which sequesters harmful molecules and is safe and effective in acute infective diarrhea. This randomized controlled multicenter trial aimed to investigate its safety and efficacy in patients with IBS-D.
Design: After a 2-week screening phase, participants were randomized into an 8-week double-blind phase, followed by an 8-week open-label and follow-up phase. Participants recorded stool consistency, pain and global symptoms in e-diaries and questionnaires. The primary outcome was the percentage of responders on a composite abdominal pain (≥ 30% decrease in the weekly score) and stool consistency (50% reduction in days per week with at least 1 stool of BSFS [Bristol Stool Form Scale] type 6 or 7) score during at least 4 weeks of the treatment period.
Results: 440 patients with IBS-D were randomized to the double-blind phase with 393 continuing to the open-label phase. The primary outcome responder rate by intention-to-treat for enterosgel versus placebo was 37.4% versus 24.3% (odds ratio = 1.95, number needed to treat = 8, p = 0.002). Enterosgel also improved stool consistency (48.5% vs. 32.5%, p < 0.0001), abdominal pain (53.3% vs. 40.2%, p = 0.003), stool frequency (treatment effect, -0.32 [95% confidence interval {CI}: -0.62 to -0.02]) and urgency (treatment effect, -0.59 [95% CI: -0.85 to -0.33]). 60% of patients reported adequate relief of symptoms after open-label treatment. Adverse event frequency was similar in both groups, with no serious events attributable to enterosgel.
Conclusion: Enterosgel is safe and effective in irritable bowel syndrome with diarrhea, providing an alternative to the limited current treatment options.